An Observational Follow-Up Study of Pediatric Patients Who Participated in a Previous Respiratory Syncytial Virus (RSV)-Induced Bronchiolitis Study of Montelukast
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Respiratory Syncytial Virus Bronchiolitis
- Sponsor
- Organon and Co
- Enrollment
- 343
- Primary Endpoint
- Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a prospective, multicenter, observational study in participants who completed the 24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of this study is to better understand the clinical and demographic correlates of asthma and atopic disorders in children (through the age of 6 years) with a history of severe RSV-induced bronchiolitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •successfully completed MK-0476 Protocol 272
- •had RSV-induced bronchiolitis at entry into Protocol 272
Exclusion Criteria
- •had developed or had been diagnosed with any illness or congenital disorder that could be immediately life threatening
Outcomes
Primary Outcomes
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
Time Frame: At 6 years of age
Asthma was defined as a positive response to the Epidemiology Questionnaire item "Has your child had wheezing or whistling in the chest in the past 6/12 months?" for the period of 12 months prior to age 6 years. Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.
Secondary Outcomes
- Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor(At 6 years of age)
- Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor(At 6 years of age)